Oxygenation targets in ICU patients with COVID-19: A post hoc subgroup analysis of the HOT-ICU trial.

"CONFLICTS OF INTEREST The authors report no conflicts of interest."

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"Twelve HOT‐ICU trial sites in Denmark, Switzerland, Norway, Finland, and the United Kingdom enrolled one or more patients with documented positive SARS‐CoV‐2 test at baseline or during the ICU stay. Written informed consent was obtained from the patients or their legal surrogate as per the relevant legislation. The HOT‐ICU trial was registered at ClinicalTrials.gov (NCT03174002) before the enrolment of the first patient. The protocol and statistical analysis plan were published before enrolment was completed.,  The HOT‐ICU trial was an investigator‐initiated, multicenter, stratified, parallel‐grouped, randomized clinical trial with 35 participating ICUs in Denmark, Switzerland, Norway, Finland, the United Kingdom, the Netherlands, and Iceland. The first patient out of 2928 patients was enrolled in the HOT‐ICU trial on June 20, 2017, and the last patient on August 3, 2020. Centralized randomization was conducted using a computer‐generated concealed allocation sequence, with permuted blocks of variable sizes, in a 1:1 ratio, stratified by site, the presence or absence of chronic obstructive pulmonary disease (COPD), and the presence or absence of active hematological malignancy. No stratification for SARS‐CoV‐2 status was implemented. The hypothesis of the HOT‐ICU trial was that a PaO2 target of 8 kPa would reduce 90‐day mortality, being the primary outcome, as compared with a PaO2 target of 12 kPa. Results did not confirm this adjusted risk ratio (RR) of 1.02 with a confidence interval (CI) 0.94–1.11. Conclusions: Targeting a PaO2 of 8 kPa may be beneficial in ICU patients with COVID‐19. These results come with uncertainty due to the low number of patients in this unplanned subgroup analysis, and insignificant tests for interaction with the main HOT‐ICU trial.: Trial registration number: ClinicalTrials.gov number, NCT03174002.: Date of registration: June 2, 2017."